Comparison of Noninvasively-Obtained Echocardiographic Doppler Parameters With Simultaneously-Measured Invasive Hemodynamics in Patients Referred for Right Heart Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Peak Exercise Cardiac Output
研究概览
简要总结
The goal is to compare patients with and without varying severity of pulmonary vascular disease based upon hemodynamic signatures, echocardiographic measures, and lung ultrasound, in tandem with expired gas metabolic testing and blood sampling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to the cardiac catheterization laboratory for invasive right heart catheterization for any reason.
- •Left Heart Disease, defined as one (or more) of the following:
- •Symptomatic HFpEF, defined by signs and symptoms of HF (dyspnea, fatigue), normal left ventricular (LV) EF (≥50% within 12 months of enrollment), and objective evidence of HF fulfilling at least one of the following criteria: Prior hospitalization for decompensated HF treated with intravenous diuretics; Invasively verified HFpEF defined by pulmonary capillary wedge pressure (PCWP) of ≥15 mmHg at rest and/or ≥25 mmHg during exercise; Clinical diagnosis of HFpEF that does not meet criteria i. or ii. but verified with NTproBNP>300 pg/ml in sinus rhythm or >900 pg/ml in AF; H2FPEF score ≥6 or HFA-PEFF score≥5 according to current guidelines.
- •Symptomatic HFrEF, defined by defined by signs and symptoms of HF (dyspnea, fatigue) and reduced EF (<50%).
- •Symptomatic valvular heart disease (VHD), defined by signs and symptoms of HF (dyspnea, fatigue) in tandem with clinically significant aortic or mitral valve disease (regurgitation and/or stenosis).
排除标准
- •Patient inability or unwillingness to undergo noninvasive echocardiography, or if echocardiography would, in the opinion of the investigator, somehow compromise the quality of data acquisition for the clinical case.
- •WSPH Group 1 Pulmonary hypertension or PH (Pulmonary arterial hypertension; including congenital heart disease)
- •Group 3 PH (Hypoxia/Lung disease-related PH)
- •Group 4 PH (Thromboembolic PH)
- •Group 5 PH (Miscellaneous)
- •Clinically significant parenchymal lung disease, hypoxemia, or lung infection
- •Amyloid/infiltrative cardiomyopathy
- •Acute Myocarditis
- •Acute coronary syndrome or revascularization within 90 days
- •Use of PH-specific drugs
- •Constrictive pericarditis
- •High output heart failure
- •HF hospitalization within the preceding 30 days
- •Severe or greater aortic (AVA < 1.0 cm2, Mean Gradient > 40 mmHg) or severe mitral (MVA < 1.0 cm) stenosis
- •Inability or unwillingness to exercise
- •Inadequate echocardiographic imaging windows
- •Inability or unwillingness to cooperate with breath holding
研究组 & 干预措施
LHD with no PH
Subjects with Left Heart Disease (LHD) and no Pulmonary Hypertension (PH; mean pulmonary artery (PA) pressure ≤20 mmHg) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
干预措施: Transthoracic Echocardiography (TTE) (Diagnostic Test)
LHD with no PH
Subjects with Left Heart Disease (LHD) and no Pulmonary Hypertension (PH; mean pulmonary artery (PA) pressure ≤20 mmHg) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
干预措施: Lung ultrasound (Diagnostic Test)
LHD with isolated PVH
Subjects with Left Heart Disease (LHD) and isolated Pulmonary Venous Hypertension (PVH; mean PA pressure>20 mmHg and PVR<3 WU) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
干预措施: Transthoracic Echocardiography (TTE) (Diagnostic Test)
LHD with isolated PVH
Subjects with Left Heart Disease (LHD) and isolated Pulmonary Venous Hypertension (PVH; mean PA pressure>20 mmHg and PVR<3 WU) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
干预措施: Lung ultrasound (Diagnostic Test)
LHD with vasoactive PVD
Subjects with Left Heart Disease (LHD) and vasoactive Pulmonary Vascular Disease (PVD; mean PA pressure>20 mmHg and PVR≥3 WU with ≥20% reduction in PVR with inhaled nitric oxide) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
干预措施: Transthoracic Echocardiography (TTE) (Diagnostic Test)
LHD with vasoactive PVD
Subjects with Left Heart Disease (LHD) and vasoactive Pulmonary Vascular Disease (PVD; mean PA pressure>20 mmHg and PVR≥3 WU with ≥20% reduction in PVR with inhaled nitric oxide) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
干预措施: Lung ultrasound (Diagnostic Test)
LHD with fixed PVD
Subjects with Left Heart Disease (LHD) and fixed Pulmonary Vascular Disease (PVD; mean PA pressure>20 mmHg, PVR≥3 WU, and PVR reduction of <20% with inhaled nitric oxide) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
干预措施: Transthoracic Echocardiography (TTE) (Diagnostic Test)
LHD with fixed PVD
Subjects with Left Heart Disease (LHD) and fixed Pulmonary Vascular Disease (PVD; mean PA pressure>20 mmHg, PVR≥3 WU, and PVR reduction of <20% with inhaled nitric oxide) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
干预措施: Lung ultrasound (Diagnostic Test)
结局指标
主要结局
Peak Exercise Cardiac Output
时间窗: Baseline
Peak exercise cardiac output (L/min) will be measured using the direct Fick technique during the invasive hemodynamic assessment by right heart catheterization.
Peak Exercise Oxygen Consumption (VO2)
时间窗: Baseline
Peak exercise VO2 (ml/kg/min) will be measured using expired gas analysis collected during the invasive hemodynamic assessment by right heart catheterization.
次要结局
- Right Ventricular function assessed by Tricuspid Annular Plane Systolic Excursion (TAPSE)(Baseline)
- Right Ventricular function assessed by tricuspid annular plane systolic excursion (TAPSE)/systolic pulmonary artery pressure (PASP) ratio(Baseline)
- Extravascular Lung Fluid Content (B-line score)(Baseline)
- Peripheral venous pressure(Baseline)
- Right Arterial Pressure (RA) in the upright position(Baseline)
- Central pressures (RA, PA, and PCWP) in the upright position(Baseline)
研究者
Barry Borlaug
Principal Investigator
Mayo Clinic